Many patients with chronic diseases or who are critically ill require frequent administration of fluids for nutritional or medicinal purposes. These medications are oftentimes delivered through an intravenous catheter such as a central venous catheter (CVC), peripherally inserted central catheter (PICC), and midline catheter, which provide vascular access and can be kept in place for durations lasting several days up to several months. Modern medical catheters that have a portion of the catheter body extending outside the patient (“percutaneous”) consist of an indwelling portion, and an external region primarily acting as a conduit to the indwelling portion. Many catheters are multi-luminal, where each lumen may serve different functions depending on anatomic location and/or dictated interventional therapy. External to the patient, the multi-luminal catheter bifurcates into single lumen lines, where the distal ends of said lines consist of a standard medical fitting (e.g., luer) for connecting infusion lines or various medical equipment, and a clamp to prevent fluid movement and air embolism when the catheter is not being accessed. The site of bifurcation is often called the “hub” or “transition” and is traditionally a molded stock connecting the indwelling catheter to the external extension(s), residing immediately adjacent to the insertion site.
Following placement of the intravascular catheter, it is often necessary to secure the catheter to the patient when used for extended periods of time to prevent axial displacement of the catheter with regards to its anatomical position. Securement of the catheter is generally accomplished by one of three means, which all involve the catheter hub: suturing the catheter hub to the patient's skin through eyelets in the “wings” extending from the molded hub; applying tape in a crisscross fashion over the catheter hub, securing the hub to the patient's skin; or placing the hub in a semi-flexible securement device which is held to the patient's skin by an adhesive base and comprises a shaped region for receiving the catheter hub. The securement methods prevent axial movement of the catheter and resist snagging or tugging of external extensions with environmental articles. These securement devices are inexpensive units that can be easily removed for cleaning of the insertion site and are discarded periodically (i.e., following daily maintenance).
Medical catheters, including urinary catheters, are manufactured using polymeric compounds such as silicone, polyethylene, polyurethane, and polytetrafluoroethylene to increase biocompatibility and longevity of use. Despite precautions, catheter-related bloodstream and catheter-associated urinary tract infections are a frequent and growing concern, having significant consequences to patient morbidity and mortality, and greatly taxing to healthcare resources. Infections stem from bacterial adsorption on the catheter surface, giving way to a prolific growth of a highly antibiotic-resistant community of cells called biofilm. Once biofilm begins to develop, antibiotic efficacy decreases due to the protective nature of the biofilm matrix which inhibits penetration of the biocide. The predominant sources of these infectious bacteria that colonize on the catheter surface are external to the patient, and, for intravenous catheters particularly, originate at the skin surface (at the insertion site) or through the frequent access of the luer fittings—which occur every time a healthcare professional connects a fluid line, collects blood samples, or attaches any number of monitoring or other devices that utilize the luer connection. Each procedure that accesses these central lines poses a potential risk to contamination.
Most of the protocols of prevention and treatment secondary to the imbued biocompatibility of the catheter involve daily cleaning of insertion site and locking the intraluminal space with potent antibiotics or anti-thrombogenic agents. Some healthcare centers utilize needleless connectors and other accessories attached at the extravascular portion of the catheter to act as an additional barrier to external contamination. In large part, technologies that attach directly to the extravascular, longitudinal portion of the catheter tube, utilize no particular feature of the catheter other than the uniformity of said catheter. For example, clamshell-like attachments are attached at any portion of the circumferential catheter, imparting the respective technology to the catheter as a non-discriminate single entity.
There are a number of technologies designed to sterilize and/or disinfect catheters, including administering germicidal ultraviolet (UV) light and ultrasound. UV light is often used commercially in microbiology labs for sterilizing labware, and long-wave ultrasound (20-100 kHz) may provide concomitant efficacy with antibiotics against bacteria through several biological mechanisms. Traditional methods for applying acoustic energy to a catheter surface require placing a large transducer above (external) to the intravascular region with the acoustic source perpendicular to the catheter. Such systems require large ultrasonic equipment and a technician to sweep the transducer head over the entire length of the implanted catheter.
It would therefore be advantageous to provide a securement device to which various active and passive technologies can be quickly and easily attached to the catheter.